Prevagen Regular Strength -- 10 mg - 30 Capsules

There may be different levels of enthusiasm toward dietary supplements, but several dynamic decades of interest, use and innovation have proven they’re an important aspect of modern life. Following quickly after discovering the nutritional basis of health in the mid-20^th century, supplements undoubtedly expanded the perspective of a healthy life from one of reaction (getting well) to one of promotion (staying well).^† At their most basic, supplements were developed as a simple, direct way to fill dietary gaps in individuals, with compounding benefits for public health.^† But the idealism from which supplements sprouted bloomed into a bumper crop that grew beyond expectations. The success and endless applications of supplements has continued to garner exceptional growth with no sign of stopping. Despite all the good that supplements have brought to individuals and society, their rapid development without constraint was ripe for some rot. After evolving into a much more complex organism than their simple roots imagined, creating a system to identify and manage the who, what and how of supplements was essential to maintaining their positive purpose.

Enter DSHEA

As the United States became more and more industrialized, the government realized the necessity and reward of protecting and promoting public health.  Mass food production meant that American diets became much more variable, and its economic incentives established the food industry as an institution with federal clout. Recognizing nutrition’s prominent role in fostering healthy citizens, therefore, the U.S. government found it prudent to plant food policy. About 50 years before supplements entered the regulatory radar, the Food, Drug and Cosmetic (FD&C) Act was written into law. This game-changing legislation, circa 1938, marked the beginning of real federal enforcement to protect the health and safety of society by establishing what meets the definition of food (and drugs, and cosmetics, of course). That initial act has undergone numerous amendments to track the advancement of knowledge, data and technology. Today, the FD&C Act has been extended to provide nuanced regulations for prescription vs. over-the-counter drugs, medical devices, food additives and – you guessed it – dietary supplements. Lagging decades behind the supplement boom, the Dietary Supplement Health & Education Act (DSHEA) of 1994 marked a profound transformation in legitimizing supplement products as a factor in keeping Americans healthy.^† Like most federal codes, DSHEA’s language is a bit laborious. Correlating with food regulations on everything from sourcing to making to marketing, its scope is intimidating. And while DSHEA (plus prerequisite knowledge of FD&C and cGMP) is essential reading for supplement-makers, even supplement-users can benefit from its answer to the persistent question: are supplements regulated, or not?

DSHEA’s 5 foundations

It’s not necessary to read every jot and tittle of DSHEA to learn how and to what extend dietary supplements are regulated. Its key takeaways can be summarized in a handy mnemonic. Here’s what DSHEA does:

DEFINES

Supplements fall under the category of food, and alongside approved food ingredients their components must fit the FDA’s definition of a vitamin, mineral, amino acid, herb or botanical, or a concentrate/extract/metabolite of one of these. And more important than what is a supplement ingredient is what it is not – a drug. DSHEA succinctly excluded the use of any drug ingredients in supplements. Regardless of which subcategory an ingredient falls under, its purpose is to “supplement” the diet, not replace the need for a complete diet.^† Supplements are ingestible by mouth as capsules, tablets, softgels, liquids or powders (gummies remain a sticky subject). DSHEA also amended the definition of food additives to allow for their inclusion in supplements. While not spelled out within DSHEA, the law directly cited and upheld current Good Manufacturing Practices (cGMP), which ensures that foods for human consumption are consistent in quality and safety. New cGMP rules that expanded on the original were created for supplements in 2007, giving directions on ingredients, labeling and claims that don’t fit foods.

SUPPORTS

The preamble to DSHEA elaborately spells out Congressional rationale for promoting the quality and safety of dietary supplements. Among 15 findings are proven links between specific nutrients and health conditions, growing healthcare costs and burdens, a need for improved health awareness, the booming supplement industry, and an admittance that the regulatory framework was, frankly, “ad hoc…patchwork.” Following the line of reasoning in DSHEA’s opening clause, the FDA sought to empower the public, the healthcare industry and the government with greater education and resources surrounding supplements. Primarily, that meant more funding for research on safety and efficacy, plus a declaration of responsibility for allowing the use of new dietary ingredients (NDI). To this end, DSHEA formally added supplements to the NDI notification process, requiring manufacturers to submit a letter to the FDA, 75 days before commercial sale, stating how the ingredient is used and why it’s safe to use as recommended on the label. Ingredients that were already consumed in foods or supplements prior to October 15, 1994 (DSHEA’s birthday), were “grandfathered” in under the assumption of safety (stay tuned if this all sounds a bit confusing).

HARMONIZES

As lawmakers confessed prior to DSHEA, regulating supplements was a bit piecemeal. FD&C proved insufficient to properly categorize not-exactly-food ingredients and lumped most of them under food additives. The problem was that, by definition, food additives can’t provide nutrition or otherwise support health. But supplement ingredients can and do.^† Drug regulations couldn’t apply, because supplements weren’t required to follow the drug approval process, nor were they intended to treat disease. While far from perfect or complete, DSHEA’s chief value was in giving dietary supplements their due. Finally, supplements were recognized and legitimized in writing, which provided a baseline of quality to separate good players from bad. By establishing a common framework, the supplement industry was given not just regulatory restrictions, but also better rules and boundaries for distinguishing their worth and value over competitors.

ENFORCES

By harmonizing definitions and requiring due diligence from manufacturers and distributors, DSHEA created a regulatory system for supplements that identified points of enforcement. Though conscientiously avoiding the all-important term “approval,” the new amendment clearly called attention to areas where supplements had overstepped into drug territory. If any words in DSHEA stand out, “adulterated” and “misbranded” do. An “adulterated,” or “misbranded,“ supplement: (1) includes a drug ingredient, (2) makes drug claims and (3) is not clearly identified as a supplement and not a drug. We have DSHEA to thank for that friendly supplement disclaimer we all know and love: “This product is not intended to diagnose, treat, cure or prevent any disease.” More simply put: “This product is not a drug.” Since the FDA acknowledged the role of dietary supplements in supporting and enhancing public health, DSHEA carefully allowed claims within these boundaries. Also known as “structure-function” claims, supplements can claim to maintain and promote normal, healthy structures and functions in the body.^† And brands are obligated to submit such claims to the FDA 30 days before putting their product on the market. Another new enforcement from DSHEA defined how supplements must be labeled to distinguish them from foods. Sharing many similarities that make labeling comparable, the fact that supplements support rather than contribute to nutrition requirements demanded a few differences to emphasize this point for consumers.^† Further nuances came about when the Supplement Facts panel made its debut in 1997. At the time of press, specific GMPs for supplements were a few years off, but DSHEA quickly yet irrefutably places quality manufacturing requirements (aka cGMP or GMP) for foods over them. Between the lines of DSHEA’s GMP section read regulations on every minute aspect of keeping supplements safe - from sourcing to sampling to shipping.

ASSIGNS

DSHEA was an impartial document, both assigning and accepting responsibility for enforcement and, notably, for advancement. More than a list of new rules, the FDA documented its commitment to making supplements better, safer, and more accessible to consumers. Putting money where its mouth is, Congress pledged significantly more dollars for research and established the Office of Dietary Supplements (ODS) to advance supplement science in collaboration with the National Institutes of Health. To make things even more official, DSHEA announced a Presidential Commission made up of seven subject matter experts that would regularly meet to survey the supplement landscape and be held accountable for updating the public on new findings and recommendations. The commission thus met one of DSHEA’s chief objectives – to empower American citizens to optimize their well-being.^†

DSHEA’s dilemmas

DSHEA sounds direct on paper, but it’s proven to be much less straightforward in practice. Grumbles quickly followed this momentous document first lauded by the dietary supplement industry. Many stakeholders continue to argue that language meant to clarify introduced confusion instead. For instance, DSHEA allows brands to “self-attest” that ingredients were used in food before 1994: that they’re rightly “generally recognized as safe” for food (commonly known as GRAS). Even for honest manufacturers and brands, much of DSHEA’s language is ambiguous and easily misapplied. Another unexpected outcome of DSHEA was an inadvertent race between supplements and drugs.  Ever-evolving health research has been a boon for both industries, and drugs tend to have the upper hand as more lucrative and FDA-approved as safe and effective. DSHEA’s liberality laid the burden of proof for safety on supplement makers, giving an inch that shady players have taken for a mile. In 2022, such oversights even triggered the American Medical Association (AMA) to call for stricter safety oversight of supplements. Other pitfalls posed against DSHEA are simply the inevitable effect of old policy that has passed its prime. What once looked powerful and promising now pales in the face of a world of e-commerce and digital advertising. In 1994, DSHEA’s $5 billion budget looked swell for the $4 billion supplement industry. Today, that investment falls far short of the ballooning $50 billion market. And auditing claims on over 80,000 products is a lot to ask of about 25 staff in the ODS.

DSHEA’s deadline

What was true 30 years ago is true today: dietary supplements can and do make a profound, democratic contribution to a healthy society.^† Even if many remain skeptical of if or how supplements are regulated, trust in products and brands remains high; the three-quarters of Americans that regularly use supplements don’t appear to be abandoning that habit anytime soon. But progress is a shared human ideal, and even if the supplement space has evolved and adapted with impressive success, DSHEA 2.0 is a worthy goal. Along with the AMA, every major voice in the supplement industry agrees with at least some reform to this aging Act. Such calls aren’t going unheard, either, with acting FDA director Dr. Cara Welch adding her say. This summer, anyone who’s anyone in supplements will gather at a summit to align and outline top priorities for DHSEA 2.0. Hot agenda items include a mandatory product listing for improved transparency and stricter requirements for making and backing up health claims. Better ingredient safety regulation will undoubtedly be central. Hopes are high that this summit will push federal approval to its peak.

Give DSHEA its due

It might be easy to grow cynical about the government or take supplement safety for granted, but DSHEA is proof that we should care too. This imperfect but insistent document has played a big role in sowing and watering what FD&C planted to empower consumer health. As you swallow your morning multivitamin or give your gut some love from a probiotic, give a nod to DSHEA as your wellness advocate.^{† †}These statements have not been approved by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent disease.